Onpoint Scope Procedure Kit & Arthrosimplicity Kit (2020-09-11)

Starting date:

September 11, 2020

Posting date:

September 25, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74003

Last updated:
2020-09-25

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  Reason
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  Affected products

Affected Products

1. ONPOINT SCOPE PROCEDURE KIT EU
2. ARTHROSIMPLICITY KIT EU

Reason

Zimmer Biomet is conducting a lot specific medical device recall for the Regenerex Taper Cap, the Onpoint Scope Procedure Kit and the Arthrosimplicity Kit due to the items not properly being aligned with the adequate gamma sterilization group. This could result in the product not being properly sterilized. The syringe pump tubing sets in the kits are affected, but the entire kits listed in the affected must be returned. This issue was identified during the annual family review for sterile product.

Affected products